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Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD

Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07224113
Enrollment
120
Registered
2025-11-04
Start date
2025-11-10
Completion date
2026-12-30
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease (CD), DGBI, IBD, Inflammatory Bowel Disease (IBD), Nutrition Assessment, Ulcerative Colitis (UC), Ultra Processed Food

Keywords

IBD, Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Ultra processed food

Brief summary

This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food-items that are high in added sugars, fats, and artificial ingredients. Participants will complete online food recalls to measure what they eat and will then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Researchers will compare changes in UPF intake between the two groups after several weeks and ask families how useful and acceptable they found the materials. The goal is to identify an effective, practical way to support healthier eating habits and long-term gut health in pediatric IBD.

Interventions

BEHAVIORALHandout-Only Intervention

Participants receive written nutrition handouts explaining what ultra-processed foods (UPFs) are, how to identify them, and practical strategies to reduce UPF intake.

BEHAVIORALHandout + Video Intervention

Participants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices.

Sponsors

Connecticut Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
Yes

Inclusion criteria

* Diagnosis of IBD (Crohn's disease, Ulcerative Colitis, IBD-U) for at least 3 months * Age 10 through \< 22 years at the time of enrollment (i.e., up to the day before the 22nd birthday) * Followed by a gastroenterologist at Connecticut Children's * IBD in clinical remission based on calculated PUCAI score \<10 or PCDAI score of \<10 * Receiving medical infusions at CCMC Infusion Center as part of IBD treatment * Participants must be on full oral intake and not have major dietary restrictions or require oral nutrition supplements

Exclusion criteria

* Following a medically prescribed or restrictive diet such as Crohn's Disease Exclusion Diet (CDED), ketogenic diet, Specific Carbohydrate Diet (SCD), low FODMAP diet, gluten-free diet, paleo, or Whole30. * Receiving any nutrition through feeding tubes (including nasogastric \[NG\], nasojejunal \[NJ\], gastrostomy \[G\], or gastrojejunostomy \[GJ\] tubes) * History of bowel surgery within 3 months of study start affecting ability to sustain normal enteral intake * Non-English-speaking participants (as translation and short-form consent processes will not be used for this study)

Design outcomes

Primary

MeasureTime frameDescription
Change in Ultra-Processed Food (UPF) IntakeBaseline and follow-up within a 4-12 week window after interventionDescription: Percent of total daily energy from NOVA Group 4 foods, comparing baseline to follow-up.

Countries

United States

Contacts

CONTACTGiselle M Davila Bernardy, MD
gdavilabernardy@connecticutchildrens.org8605459560
PRINCIPAL_INVESTIGATORGiselle Davila-Bernardy, MD

Connecticut Children's Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026